Harvard doctor calls for greater supplement regulation in NEJM

By Michael Johnsen

WASHINGTON — The New England Journal of Medicine on Thursday published an op-ed online that called for more rule-making to govern dietary supplements in an effort to rein in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.

Author Pieter Cohen, author of the opinion and an assistant professor of medicine at Harvard Medical School, in his opening paragraph pointed to the recent recall of the product Zotrex. Marketed as a dietary supplement, the product reportedly contained the fictitious ingredient "Ophioglossum polyphyllous," but in actuality contained a drug analogue of the active ingredient in the erectile dysfunction pharmaceutical Viagra (sildenafil).

Following a Food and Drug Administration investigation of NovaCare, the company that distributed that product online, the U.S. Attorney's Office in September 2011 revealed a 31-count indictment alleging NovaCare proprietor Kelly Dean Harvey purposefully thwarted FDA regulations after the agency first started warning consumers about NovaCare products in 2009 (the product at the time was called "Stiff Nights"). Charges against Harvey include one count of conspiracy, 12 counts of wire fraud, nine counts of mail fraud and nine counts of money laundering, according to reports. He pleaded not guilty to those charges in November.

"Although Zotrex represented a particularly brazen violation of the law," wrote Cohen, an assistant professor of medicine at Harvard Medical School in the opening paragraph, "surprisingly, many new supplement ingredients are introduced into the market as [those found in Zotrex were], without any regulatory oversight." Specifically, Cohen calls for clinical trials establishing safety be a pre-requisite for new dietary ingredients to reach the market.

"Unfortunately, Dr. Cohen’s article provides a bit of a bait and switch, perhaps unwittingly," claimed Duffy MacKay, VP scientific and regulatory affairs Council for Responsible Nutrition, in a statement released Thursday. "In calling for more stringent oversight of legitimate supplement products, he holds up a poster child for the problem of illegally spiked products. The product Dr. Cohen references in his commentary, by law is illegal and not a dietary supplement," he noted. "Dr. Cohen refers to the manufacturer of this product as a ‘respected company’ when in fact it is a company that broke a myriad of existing laws, including adding undeclared ingredients — specifically drugs — to the product."

In response to Cohen's call for clinical trials vetting safety as a prerequisite, MacKay noted that, unlike pharmaceutical ingredients, supplements do not necessarily have an immediate and dramatic effect on an acute symptom or condition, "and in general, they have a wider margin of safety," he said.